Lupin informs about receipt of warning letter from US FDA

19 Sep 2019 Evaluate

Lupin has informed that the Company has received a warning letter from the US FDA for its Mandideep (Unit-1) facility. This is subsequent to an earlier intimation received from the US FDA in March 2019 wherein the agency had classified its inspection conducted at the said facility in December 2018 as ‘Official Action Indicated’ (OAI). There are no DMF and ANDA applications pending review or approval from the Mandideep (Unit-1) facility and the Company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility. It is committed to addressing the concerns raised by the US FDA and will work with the US FDA to resolve these issues at the earliest. The company upholds quality and compliance issues with utmost importance and remains committed to be compliant with CGMP quality standards across all its facilities. This may be considered as a disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. 

The above information is a part of company’s filings submitted to BSE.

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